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Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01209429
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : September 13, 2011
Sponsor:
Information provided by (Responsible Party):
Birgitte Nellemann, University of Aarhus

Tracking Information
First Submitted Date  ICMJE September 24, 2010
First Posted Date  ICMJE September 27, 2010
Last Update Posted Date September 13, 2011
Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
Description of intracellular pathways to clarify the interplay between calorie restriction, SIRT1, STATb5, and the GH/IGF-I axis [ Time Frame: 6 hour study days ]
All study days consists of 3 hour basic periods and 3 hours hyperinsulinemic, euglycemic clamp.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction
Official Title  ICMJE Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction
Brief Summary This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men on calorie restriction on 4 study days with fat and skeletal muscle biopsies.
Detailed Description

It has been shown that calorie restriction enhances the length of life in yeast, worms, fish and rodent. Whether this elongation of life due to calorie restriction can be applied to humans is not known. However, it is a fact that calorie restriction will decrease the risk of developing metabolic disturbances such as diabetes, hypertension and atherosclerosis.

On the molecular level the specific relations are not fully understood. This study will investigate the possible connection between SITR1 and the relation to the GH/IGF-I axis and STAT5b in healthy men. The participant will fast 42 and 12 hours respectively, and have GH or placebo infusions. The design is a classical 2x2 design and will be randomized.

Knowledge of the interactions between calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis will apply important information about the relations between aging, energy metabolism and metabolic disturbances.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: GH hormone infusion
    Norditropin 30 ng/kg/min
    Other Names:
    • Norditropin
    • Genotropin
  • Behavioral: 42 hour fast
    The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed
    Other Name: No other name
  • Behavioral: 12 hour fast
    12 hour fast will be used as a control scenario to 42 hour fast
    Other Name: No other name
Study Arms  ICMJE
  • Experimental: 42 hour fast/GH infusion
    Interventions:
    • Drug: GH hormone infusion
    • Behavioral: 42 hour fast
  • Experimental: 42 hour fast/Placebo infusion
    Intervention: Behavioral: 42 hour fast
  • Experimental: 12 hour fast/GH infusion
    Interventions:
    • Drug: GH hormone infusion
    • Behavioral: 12 hour fast
  • Placebo Comparator: 12 hour fast/Placebo infusion
    Intervention: Behavioral: 12 hour fast
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 24, 2010)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy lean men
  • age >18

Exclusion Criteria:

  • metabolic disturbances
  • alcohol drug abuse
  • malign disease: current or previous
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01209429
Other Study ID Numbers  ICMJE M-20100150
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Birgitte Nellemann, University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jens Otto L Jørgensen, Professor University Hospital of Aarhus
PRS Account University of Aarhus
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP